41 data-"https:" "https:" "https:" "https:" "https:" "https:" "https:" "Univ" "Univ" Fellowship research jobs at Center for Drug Evaluation and Research (CDER)

FDA Fellowship - Enhancing Oncology Dose Optimization Through Patient-Reported Outcome Exposure-Response Analysis

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 1 hour ago

of novel PRO-based ER analyses of tolerability associated drug exposure related adverse events to inform standard ER analyses for safety and provide complementary tolerability data to improve dosage

FDA Computational Toxicology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour ago

(QSAR) models. The selected participant will learn to harvest and interpret toxicology data, develop and apply QSAR models, and communicate research results to both internal and external stakeholders

FDA Fellowship - Evaluation of Non-Inferiority Margin for Drug Products

Center for Drug Evaluation and Research (CDER) | United States | 16 days ago

macular edema (DME), with potential expansion to other retinal indications, through network meta-analysis and patient matching methodologies applied to historical and recent clinical data. The participant

FDA Bioequivalence of Complex Generic Products Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour ago

foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page  of the program website for information about the valid immigration statuses

FDA Fellowship - Endpoint Strategy Selection and Statistical Analysis Plan for Non-Malignant Hematologic Disease

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 1 hour ago

under realistic data-generating scenarios (endpoint correlation, effect assumptions, alpha requirements), compare study power and other metrics (e.g., probability that endpoints are individually

FDA Fellowship - Development of AI Technologies for Causality Assessment

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | about 1 hour ago

for causality assessments of individual case safety reports. The research project is supported under 21st Century Cures Act (2016) Section 3022 (Drug Safety) to evaluate real-world evidence data on drug’s use

FDA Research Fellowship: Neurodevelopmental Assessment of Prenatal Analgesic Exposure Using Translational Models

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | about 1 hour ago

of great interest to CDER. The resulting data may impact guidelines over the use of a drug of interest in pregnancy. The National Center for Toxicological Research (NCTR) is currently investigating

FDA Biomarker Qualification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour ago

miscategorization of subjects with potential DILI risk during regulatory review.  Through this opportunity, you will cooperate in research and training activities related to computer modeling and statistical analyses

FDA Fellowship - In Silico and In Vitro Approaches to Inform Polypharmacy and Patient Effects on Opioid Overdose

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 1 hour ago

and become efficient in using various computing languages, such as R, C, and Python, to develop mechanistic models to simulate human pharmacology and utilize High Performance Computing for data analysis

FDA Postdoctoral Fellowship in the Application of Microphysiological Systems to Study the Blood-Milk Barrier

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour ago

barrier integrity and permeability, and compare in vitro findings with available clinical and pharmacokinetic data to assess model performance. These activities will advance understanding of maternal–infant